ABL90 FLEX Analyzer 393-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 05700693930909), received between Nov 17, 2017 and Jun 4, 2026 — classified as 7 injuries, 105 malfunctions.

The most frequently reported specific device problem is “High Readings” (22 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Mar 21, 2025Open, Classified

   ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.

   Z-1659-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026High Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO COMPLAINT, CUSTOMER REPORTED DISCREPANCY (FALSE HIGH) ON PATIENT SAMPLE FROM THE ARTERIAL BLOOD GAS ABL90 FLEX ANALYZER (SERIAL NUMBER (B)(6)).

  Patient problems: Bone Fracture(s)

  MAUDE report 25390008 ↗
• MalfunctionMay 13, 2026Low Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, THE ELECTROLYTE MEASUREMENTS (SODIUM CNA+) FROM THE ABL90 FLEX ANALYZER (SERIAL NUMBER: (B)(6) ARE DIFFERENT FROM THE MEASUREMENTS OBTAINED FROM ANOTHER INSTRUMENT ON THE SAME SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158341 ↗
• MalfunctionJan 22, 2026Low Readings

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER NOTIFIED ON (B)(6) 2026 AT 1:57 PM THAT THE RADIOMETER BLOOD GAS ANALYZER ABL90 FLEX ANALYZER (SERIAL NUMBER (B)(6) GAVE ERRORS AND LOW VALUES ON TOTAL HEMOGLOBIN (THB), COMPARED TO ANOTHER ABL90 FLEX ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144173 ↗
• MalfunctionJan 22, 2026Low Readings

  RADIOMETER REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT THE CUSTOMER EXPERIENCED INACCURATE THB (HEMOGLOBIN) RESULTS WITH THEIR ABL90 FLEX BLOOD GAS ANALYZER (SERIAL NO; (B)(6) ON (B)(6) 2025. THE CUSTOMER DESCRIBES THAT THE MEDICAL STAFF USED THE ANALYZER FOR TESTING PATIENTS' BLOOD GAS, BLOOD OXYGEN, ELECTROLYTES, AND METABOLITES. UNDER NORMAL OPERATING CONDITIONS, THE MEASURED HEMOGLOBIN CONCENTRATION WAS ONLY 6.5 G/DL. IF THIS VALUE WERE ACCURATE, IT WOULD INDICATE MASSIVE BLEEDING REQUIRING EMERGENCY TREATMENT. HOWEVER, THE PATIENT EXHIBITED NO SUCH SYMPTOMS. THIS NECESSITATED A REPEATED COMPLETE BLOOD COUNT, WHICH SHOWED A HEMOGLOBIN CONCENTRATION OF 11.1 G/DL, WITHIN THE NORMAL RANGE. THIS ADVERSE EVENT INCREASED THE PATIENT'S NEEDLE-STICK PAIN AND RESULTED IN ADDITIONAL MEDICAL EXPENSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24143801 ↗
• MalfunctionJan 21, 2026High Readings

  RADIOMETER COMPLAINT REFERENCE (B)(4). ACCORDING TO THE CUSTOMER, THEY EXPERIENCED FALSE HIGH PCO2 RESULTS FROM THE ABL90 FLEX BLOOD GAS ANALYZER AS COMPARED WITH ANOTHER ABL90 ANALYZER, EVEN THOUGH THERE IS NO ERROR FOR CALIBRATION AND QUALITY CONTROL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129358 ↗
• MalfunctionJan 9, 2026Low Readings

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO COMPLAINT, THE HOSPITAL REPORTED THAT ON (B)(6) 2025, AFTER DRAWING AN ARTERIAL BLOOD GAS SAMPLE, THE NURSE FOUND THAT THE PATIENT'S PO2 WAS TOO LOW ON ABL90 FLEX ANALYZER (SERIAL NUMBER: (B)(6)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019229 ↗
• MalfunctionJan 5, 2026Output Problem

  RADIOMETER REFERENCE NUMBER: (B)(4) ACCORDING TO THE COMPLAINT THE HOSPITAL REPORTED, ON (B)(6) 2025, AT 5:30 PM, AFTER COLLECTING THE PATIENT'S ARTERIAL BLOOD, TESTING WAS PERFORMED. FIVE MINUTES LATER, THE ABL90 FLEX ANALYZER DID NOT PRODUCE ANY RESULTS, DELAYING THE PATIENT'S TREATMENT. AFTER REPLACING THE SENSOR CASSETTE (LOT NUMBER: R0330) AND RETESTING, THE SYSTEM RETURNED TO NORMAL. NEW INFORMATION RECEIVED ON (B)(6) 2025: CONFIRMED SEQUENCE OF EVENTS: BEFORE THE MEASUREMENT, THE ANALYZER DID NOT ISSUE ANY ALARMS AND WAS IN NORMAL STATUS. THE CUSTOMER LOADED THE SAMPLE ONTO THE ANALYZER AND THEN LEFT, WAITING FOR THE MEASUREMENT TO BE COMPLETED AUTOMATICALLY. APPROXIMATELY A FEW MINUTES LATER, THE CUSTOMER RETURNED TO THE ANALYZER TO CHECK THE MEASUREMENT RESULTS AND FOUND THAT NO RESULT HAD BEEN GENERATED. THE ANALYZER DISPLAYED ERROR CODE 1311. THE CUSTOMER THEN REINSTALLED THE SC, BUT THE ANALYZER DISPLAYED AN ALARM THE CHIP DATA CANNOT BE READ. FINALLY, AFTER THE CUSTOMER REPLACED THE SC WITH A NEW ONE AND INSTALLED IT, THE ISSUE WAS RESOLVED. THE CUSTOMER RECOLLECTED THE PATIENT SAMPLE AND COMPLETED THE MEASUREMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955626 ↗
• MalfunctionNov 4, 2025Calibration Problem; Output Problem; Calibration Problem; Output Problem

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT THE HOSPITAL REPORTED ON (B)(6) 2025, THAT THE PATIENT WAS ADMITTED FOR TREATMENT DUE TO DYSPNEA AND UNEXPLAINED CONVULSIONS. AT 22:08 ON (B)(6) 2025, THE EMERGENCY NURSE DREW A BLOOD SAMPLE FROM THE PATIENT. WHEN THE SAMPLE WAS TESTED USING THE ABL90 FLEX ANALYZER (SERIAL NO; (B)(6), THE SC (SENSOR CASSETTE) FAILED CALIBRATION, AND NO TEST DATA COULD BE DISPLAYED. AS A RESULT, A NEW SAMPLE HAD TO BE DRAWN AND SENT TO THE LABORATORY FOR TESTING, WHICH DELAYED CLINICAL RESUSCITATION EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23463162 ↗
• MalfunctionOct 28, 2025High Readings; High Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON 2025-10-19 SAMPLES WERE MEASURED ON THE ABL90 FLEX ANALYZER (SERIAL NUMBER: (B)(6) WITH FALSE HIGH POTASSIUM MEASUREMENTS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23400783 ↗
• MalfunctionOct 15, 2025Low Readings; Low Readings

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER REPORTED THAT SINCE (B)(6) 2025 THEY EXPERIENCED 10 PATIENT SAMPLES WITH GLUCOSE (GLU) RESULT <0,0. ON THE ABL90 FLEX ANALYZER (SERIAL NUMBER (B)(6)) IT IS MARKED WITH 3 ARROWS DOWN, AND OUT OF REPORTABLE RANGE. THE RESULTS HAVE BEEN TRANSMITTED TO LIS AS <0,2. THE NURSES AND DOCTORS KNOWS THIS RESULT IS NOT POSSIBLE ON A NEWBORN, SO THEY HAVE REPEATED A GLUCOSE TEST ON ACCUCHECK AND TRUSTED THE RESULT FROM HERE. THEY HAVE NOT TREATED ANY PATIENTS FROM THE ABL90 FLEX ANALYZER RESULTS, AND THE LAB HAVE CANCELLED THE RESULTS IN THE JOURNAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287751 ↗
• MalfunctionSep 15, 2025Output Problem; Output Problem

  RADIOMETER REFERENCE NUMBER: (B)(4) ACCORDING TO THE COMPLAINT THE CUSTOMER EXPERIENCED FALSE HIGH GLUCOSE (GLU) RESULTS ON THEIR ABL90 FLEX ANALYZER (SERIAL NO; (B)(6). THE HOSPITAL REPORTED, ON THE MORNING OF (B)(6) 2025, THE DOCTOR ORDERED AN ARTERIAL BLOOD DRAW TO TEST BLOOD GASES, LACTATE, GLUCOSE, AND ELECTROLYTES. AFTER DRAWING THE BLOOD, THE NURSE PERFORMED THE TEST ON THE ABL90 FLEX ANALYZER. THE RESULT SHOWED A GLUCOSE LEVEL OF 18.8 MMOL/L, WHICH WAS REPORTED TO THE DOCTOR. THE DOCTOR INSTRUCTED A REPEAT TEST USING A RAPID GLUCOSE METER, WHICH YIELDED A VALUE OF 7.7 MMOL/L. SUSPECTING A MALFUNCTION OF THE SENSOR CASSETTE (LOT; R0321) IN THE ANALYZER, THE MEDICAL STAFF IMMEDIATELY CONTACTED THE ENGINEER. THE ENGINEER INSTRUCTED TO RECALIBRATE TWICE. AFTER COMPLETING THE RECALIBRATION, A FOLLOW-UP TEST WAS PERFORMED, AND THE GLUCOSE RESULT WAS 4.2 MMOL/L, WHICH IS WITHIN THE NORMAL RANGE. NO ADVERSE EFFECTS WERE OBSERVED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050539 ↗
• MalfunctionSep 5, 2025Computer Software Problem; Computer Software Problem

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO COMPLAINT, CUSTOMER REPORTED THAT SINCE (B)(6) 2023 THE CUSTOMER EXPERIENCE INTERMITTENTLY WHEN RUNNING A SAMPLE, THE ABL90 FLEX ANALYZER (SERIAL NUMBER (B)(6)) SOFTWARE FREEZES COMPLETELY BEFORE THE SAMPLE PROCESS IS COMPLETED. ANALYZER HAS TO BE REBOOTED TO RESTORE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975936 ↗
• MalfunctionSep 3, 2025Low Readings; Low Readings

  RADIOMETER REFERENCE (B)(4). ACCORDING TO THE COMPLAINT, DURING A ROUTINE BLOOD GAS TEST FOR A PATIENT, THE NURSE OBSERVED ABNORMAL VALUES FROM THE ABL90 FLEX (SERIAL NUMBER (B)(6) FOR GLUCOSE OF 1.2 MMOL/L AND LACTATE OF 1.7 MMOL/L. TO ENSURE ACCURACY, THE NURSE REPLACED THE ABL90 FLEX SOLUTION PACK (LOT NUMBER DY26) AND REPEATED THE TEST, WHICH THEN RETURNED NORMAL VALUES OF 6.8 MMOL/L FOR GLUCOSE AND 1 MMOL/L FOR LACTATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22950542 ↗
• MalfunctionAug 22, 2025High Readings; High Readings

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT THE HOSPITAL REPORTED, THE PATIENT WAS ADMITTED FOR TREATMENT. AT 06:17 ON (B)(6) 2025, A BLOOD GAS ANALYSIS WAS PERFORMED ON AN ABL90 FLEX ANALYZER (SERIAL NO; (B)(6) AS PER MEDICAL ORDERS, AND THE RESULTS SHOWED SODIUM (NA): 246 MMOL/L. HOWEVER, THE BIOCHEMICAL BLOOD TEST RESULTS FROM THE LABORATORY INDICATED A SODIUM LEVEL OF 143 MMOL/L, REVEALING A SIGNIFICANT DISCREPANCY THAT SEVERELY IMPACTED THE DIAGNOSIS AND TREATMENT OF THE PATIENT. AFTER RESTARTING THE ANALYZER, A REPEAT TEST WAS CONDUCTED, SHOWING SODIUM: 142 MMOL/L. IT IS SUSPECTED THAT THE DEVICE EXPERIENCED AN UNEXPLAINED, SPORADIC SYSTEM MALFUNCTION. THE INCIDENT WAS IMMEDIATELY REPORTED TO THE EQUIPMENT DEPARTMENT FOR INSPECTION AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870722 ↗
• MalfunctionAug 1, 2025High Readings; High Readings

  RADIOMETER REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT THE CUSTOMER REPORTED, ON (B)(6) 2025, A BEDSIDE BLOOD GAS TEST WAS CONDUCTED FOR A PATIENT ON AN ABL90 FLEX ANALYZER (SERIAL NO; (B)(6), REPORTING A POTASSIUM (K) LEVEL OF 7.2 MMOL/L, WHICH WAS ABNORMAL. VENOUS BLOOD WAS IMMEDIATELY COLLECTED FROM THE PATIENT AND SENT TO THE HOSPITAL LABORATORY FOR RE-EXAMINATION, WHICH SHOWED A K LEVEL OF 4.0 MMOL/L, WITHIN THE NORMAL RANGE. THERE WAS A SIGNIFICANT DISCREPANCY BETWEEN THE BEDSIDE BLOOD GAS TEST AND THE VENOUS TEST RESULTS. INFORMATION RECEIVED 19AUG2025: ACCORDING TO THE COMPLAINT, THE ENGINEER INSPECTED THE ANALYZER AND FOUND NO ISSUES. EXTERNAL QUALITY CONTROLS WERE PERFORMED, AND COMPARATIVE VERIFICATION WAS CONDUCTED WITH THE LABORATORY'S OTHER EQUIPMENT, WITH NO ABNORMALITIES DETECTED IN THE ABL90. THEREFORE, THE ENGINEER SPECULATED THAT THE ISSUE MIGHT HAVE BEEN CAUSED BY PRE-ANALYTICAL ERRORS SUCH AS HEMOLYSIS. TRAINING HAS BEEN ARRANGED FOR THE CUSTOMER. THE CUSTOMER DID NOT PROVIDE A SERVICEDUMP. DURING THE INQUIRY, IT WAS DISCOVERED THAT THE CUSTOMER HAD REPORTED AN INCORRECT ANALYZER SERIAL NUMBER IN THE AE REPORT. THE ACTUAL ANALYZER INVOLVED IN THE INCIDENT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685783 ↗
• MalfunctionJul 8, 2025High Readings; High Readings

  RADIOMETER REFERENCE (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2025, THE MEDICAL STAFF CONDUCTED TESTS ON A PATIENT FOR BLOOD GAS, BLOOD OXYGEN, AND ELECTROLYTES. THE ABL90 FLEX ANALYZER (SERIAL NUMBER (B)(6) MEASURED A POTASSIUM LEVEL OF 6.5 MMOL/L, WHILE THE BIOCHEMICAL EQUIPMENT MEASURED A POTASSIUM LEVEL OF 4.25 MMOL/L, RESULTING IN A DIFFERENCE OF 2.25 MMOL/L. THE ANALYZER'S POTASSIUM MEASUREMENT WAS INACCURATE, INDICATING A CRITICAL VALUE. DUE TO THE ANALYZER'S HIGH POTASSIUM READING, THE CHILD WAS MONITORED WITH AN ECG, AND THE NUTRITIONAL SOLUTION IN USE WAS REPLACED, SERIOUSLY INTERFERING WITH CLINICAL WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436153 ↗
• MalfunctionJul 4, 2025Unable to Obtain Readings; Calibration Problem; Unable to Obtain Readings; Calibration Problem

  ACCORDING TO THE COMPLAINT (B)(4), THE ABL90 FLEX ANALYZER (SERIAL NUMBER: (B)(6) GAVE FREQUENT 1070 ERROR CODES ON THE CALCIUM RESULTS. THE CUSTOMER REPORTS THAT THIS ISSUE OCCURS EVERY DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403034 ↗
• MalfunctionJul 3, 2025Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  RADIOMETER COMPLAINT REF. (B)(4). ACCORDING TO THE COMPLAINT, ON JUNE 20, 2025, AT 10:00 AM, THE ABL90 FLEX ANALYZER MALFUNCTIONED. AN ENGINEER WAS CONTACTED TO INSPECT THE DEVICE ON-SITE, AND IT WAS DIAGNOSED THAT THE OXI MODULE WAS FAULTY. AFTER REPLACING THE SPARE PART, THE ANALYZER RETURNED TO NORMAL OPERATION. THERE WERE NO ALARMS FOR CALIBRATION AND QC AND THE ANALYZER DID NOT DISPLAY AS UNAVAILABLE BEFORE THE CUSTOMER CHECKED THE SAMPLE. THEN THE CUSTOMER LOADED THE SAMPLE FOR TESTING, AND THE INSTRUMENT DISPLAYED THE TEST RESULT ALONG WITH ERROR CODE 0581 (OXI SPECTRUM MISMATCH).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394203 ↗
• MalfunctionJun 12, 2025Computer Software Problem; Computer Software Problem

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT THE HOSPITAL REPORTED, WHILE PERFORMING A BLOOD GAS TEST FOR A PATIENT, AFTER COMPLETING THE TEST AND PRINTING THE REPORT, IT WAS DISCOVERED THAT THE INTERNAL CLOCK OF THE ABL90 FLEX ANALYZER (SERIAL NO; (B)(6) WAS INCORRECT. THE CORRECT TIME WAS 17:37 ON (B)(6) 2025, BUT THE ACTUAL DISPLAYED TIME WAS 11:57 ON (B)(6) 2023. THE INCORRECT TIME DISPLAY CAUSED THE REPORT TIME TO NOT MATCH THE ACTUAL TEST TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192989 ↗
• MalfunctionMay 7, 2025Calibration Problem; Calibration Problem

  ACCORDING TO THE COMPLAINT ON 2025-04-11 THE ABL90 FLEX ANALYZER (SERIAL NUMBER: (B)(6)) FAILED CALIBRATION DURING USE AND THE TEST RESULTS FOR THE OXYGEN PARAMETERS DISPLAYED A "?" WITH ERROR CODE 0581. THE ISSUE WAS FOUND TO BE RELATED TO THE SOLUTION PACK (LOT NUMBER:DF05). AFTER REPLACING THE SOLUTION PACK, THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974573 ↗
• MalfunctionMar 27, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE COMPLAINT, ON (B)(6) 2025 A BLOCKAGE OCCURRED IN THE INLET TUBE OF THE ABL90 FLEX ANALYZER (SERIAL NUMBER: (B)(6). THIS PREVENTED THE PATIENT'S SAMPLE FROM BEING TESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707236 ↗
• MalfunctionMar 25, 2025Low Readings; Low Readings

  ACCORDING TO THE COMPLAINT, ON (B)(6) 2025 SAMPLES WERE MEASURED ON THE ABL90 FLEX ANALYZER (SERIAL NUMBER: (B)(6) AND SHOWED A PCO2 RESULT OF 10.7MMHG. THIS WAS INCONSISTENT WITH THE PATIENT'S CONDITION. THE USER DID NOT MAKE ANY ADJUSTMENTS TO THE VENTILATOR PARAMETER OF THE PATIENT, BASED ON THIS MEASUREMENT. RADIOMETER ENGINEER WAS CONTACTED, AND AFTER QC AND INSPECTION OF THE ANALYZER, THE SENSOR CASSETTE (LOT NUMBER: R0287) WAS REPLACED. A REPEAT MEASUREMENT WAS CONDUCTED AND A PCO2 RESULT OF 40.7MMHG WAS OBTAINED. BASED ON THIS, THE CUSTOMER HAD REPORTED THE 10.7MMHG AS FALSE LOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687301 ↗
• MalfunctionMar 6, 2025Low Readings; Low Readings

  ACCORDING TO COMPLAINT, THE CUSTOMER REPORTED THAT THEY EXPERIENCED CALCIUM ION (CA²) DEVIATION WITH THE ABL90 FLEX ANALYZER (SERIAL NUMBER 090R1051N070) COMPARED TO THE LAB. WITH 2 DIFFERENT SENSOR CASSETTE (SC90). SAMPLE ID (B)(6), (B)(6) 2025 05:22, CA² 0,35 MMOL/L (DISCREPANT VALUE). SAMPLE ID (B)(6), (B)(6) 2025 05:23, CA² 0,68 MMOL/L (DISCREPANT VALUE). (B)(6) 2025, CA² 3,8 MMOL/L (COMPARISION VALUE). LAST FEW WEEKS, CA² ~ 1 MMOL/L (COMPARISION VALUE). HENCE THE CUSTOMER EXPERIENCED FALSE LOW CA² MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21533424 ↗
• MalfunctionMar 4, 2025High Readings; High Readings

  ACCORDING TO THE COMPLAINT, AN ARTERIAL SAMPLE OF PATIENT ON THE ABL90 FLEX ANALYZER (SERIAL NO. (B)(6)) GAVE CREDIBLE VALUES FOR ALL PARAMETERS EXCEPT A LACTATE OF 6.4 MMOL/L. A SECOND VENOUS SAMPLE WAS TAKEN FROM THE SAME PATIENT ONE HOUR LATER AND MEASURED ON ANOTHER ANALYZER WHICH GAVE A MORE CREDIBLE RESULT FOR LACTATE OF 2.3 MMOL/L. AFTER 2 HOURS A THIRD SAMPLE WAS MEASURED ON BOTH ANALYZERS WITH VERY SIMILAR RESULTS ARE FOR LACTATE (5.6 AND 5.7 MMOL/L)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512501 ↗
• MalfunctionFeb 19, 2025High Readings; High Readings

  ACCORDING TO THE COMPLAINT THE HOSPITAL REPORTED, ON (B)(6) 2025, AFTER PERFORMING AN ARTERIAL BLOOD DRAW AND PROCEEDING WITH THE BLOOD ANALYSIS, THE PCO2 VALUE WAS FOUND TO BE HIGHER THAN NORMAL. THE BLOOD GAS VALUES WERE INACCURATE, WHICH COULD AFFECT THE DIAGNOSIS OF THE PATIENT'S CONDITION. IT IS NECESSARY TO REDRAW THE BLOOD AND USE A DIFFERENT BLOOD GAS ANALYZER FOR TESTING. NEW INFORMATION RECEIVED 14FEB2025: AT 1:10 AM ON (B)(6), USING (B)(6), THE PATIENT SAMPLE TEST RESULT SHOWED PCO2 106 MMHG. THE CUSTOMER BELIEVES THIS RESULT DOES NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. AT 1:17 AM ON (B)(6) USING (B)(6), ANOTHER ANALYZER AT THE HOSPITAL TESTED THE SAME SAMPLE AND OBTAINED A. RESULT OF 33.9 MMHG. THE ENGINEER REPORTED THAT BEFORE THE CUSTOMER TESTED THE SAMPLE, (B)(6) HAD ALREADY FAILED PCO2 CALIBRATION AND QC WITH ERROR CODES 0377 AND 0589. AS A RESULT, THE SOLUTION PACK (SP) WAS REPLACED FOR THE CUSTOMER. NEW INFORMATION RECEIVED 26FEB2025: SERVICE DUMP RECIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21408650 ↗